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QUESTIONS AND ANSWERS

The PopART HIV Prevention Study

The Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) study, also known as HPTN 071, is an HIV prevention trial that will assess whether house-to-house voluntary HIV testing and immediate treatment of HIV infection, along with other proven HIV prevention measures, can substantially reduce the number of new HIV infections across communities in South Africa and Zambia.

2.

Who will participate in the PopART study, and where is the study being conducted?

The PopART study will involve nine communities in South Africa’s Western Cape and 12 communities in Zambia that together have a population of 1.2 million. The study team will enroll and follow a representative sample of 52,500 men and women ages 18 to 44 years from these 21 communities.

The clinical trial is being conducted in South Africa and Zambia because HIV prevalence there is among the highest in the world. An estimated 12.5 percent of adults in Zambia and 17.3 percent of adults in South Africa were HIV-infected in 2011, the most recent year for which data are available.

3.

Who is sponsoring and funding the PopART study?

The PopART study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is funded primarily by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), administered by the Office of the Global AIDS Coordinator. Additional funds are being provided by the International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation, as well as from NIAID, the National Institute on Drug Abuse and the National Institute of Mental Health, all part of NIH.

4.

Who is leading the PopART study?

The study is being led by investigators at the London School of Hygiene & Tropical Medicine in collaboration with scientists at Imperial College London, the Zambia AIDS-Related Tuberculosis (ZAMBART) Project and the Desmond Tutu TB Centre at Stellenbosch University, South Africa.

The protocol chair is Richard Hayes, M.Sc., D.Sc., F.Med.Sci., a professor of epidemiology and international health at the London School of Hygiene & Tropical Medicine. The protocol co-chair is Sarah J. Fidler, M.B.B.S., Ph.D., a reader in the Department of Medicine at Imperial College London.

5.

Who is conducting the PopART study, and when will it conclude?

The research is being conducted by scientists at the NIH-funded HIV Prevention Trials Network, the London School of Hygiene & Tropical Medicine, Imperial College London, the ZAMBART Project and the Desmond Tutu TB Centre at Stellenbosch University, South Africa.

PEPFAR partners will provide HIV care and treatment to the study communities under the direction of the U.S. Agency for International Development and the U.S. Centers for Disease Control and Prevention.

The PopART study is expected to conclude in 2019.

6.

What is the PopART study design?

The PopART study is a three-arm, cluster-randomized, longitudinal study being implemented in 21 clusters, i.e., 21 communities. These communities have been grouped into triplets based on location and comparable HIV prevalence. Within each triplet, the communities were assigned at random to each of the three study arms. Each arm contains 7 communities with a total population of roughly 400,000 individuals, half of them adults.

The adults in arms A and B are receiving a combination HIV prevention package, while the adults in arm C are serving as a control and receiving the standard of care for HIV prevention and treatment in their country.

The combination HIV prevention package includes house-to-house, voluntary HIV testing offered at annual intervals and steps to connect those who test positive for the virus to care at local health centers. The package also includes the promotion of voluntary medical circumcision to men who are not HIV-infected, the promotion of steps to prevent transmission of the virus from mother to child, the referral of people with other sexually transmitted infections to treatment, and the provision of condoms.

As an additional preventive measure, the individuals in arm A who test positive for HIV are receiving the opportunity to begin treatment for their infection right away so as to reduce their infectiousness. In contrast, people in arm B who test positive for the virus are being offered treatment at the stage of infection recommended by their country’s HIV treatment guidelines.

The study team will measure the impact of the HIV prevention package by determining the number of new HIV infections among a random sample of 52,500 adults ages 18 to 44—2,500 from each community—who are followed for 3 years. Any statistically significant difference in HIV incidence between arms A and B will illustrate the additional preventive benefit of starting antiretroviral therapy as soon as a person tests positive for the virus.

7.

Why is the PopART study important?

The PopART study is building on the results of the landmark, NIAID-funded HPTN 052 trial, which found that HIV-infected individuals who start antiretroviral drug therapy for HIV early, when their immune systems are relatively healthy, dramatically reduce the risk of transmitting the virus their heterosexual partners. While HPTN 052 was conducted among fewer than 1,800 heterosexual couples in stable relationships, the current study will determine whether house-to-house voluntary HIV testing and early treatment of HIV within a diverse population of hundreds of thousands of adults is feasible and helps reduce the rate of new infections among them. Mathematical models indicate that, over time, this strategy could substantially reduce both the number of new infections and the overall number of HIV cases in the population. It is also believed that early treatment will reduce the risk of disease progression in infected individuals.

Moreover, scientific evidence to date indicates that a combination of HIV prevention methods will be necessary to bring HIV transmission under control, particularly in the most severely affected countries. The PopART trial is one of the first to rigorously examine how well combinations of proven HIV prevention methods can be delivered to a large population in sub-Saharan Africa and whether these combinations reduce the rate of new HIV infections at the population level.

Data from the PopART trial will be combined with cost data and mathematical models to estimate the cost-effectiveness of the study interventions, which could help guide public health policy.

8.

How will the safety of study participants be ensured?

An independent Data and Safety Monitoring Board (DSMB) will carefully monitor the safety and HIV status of the 52,500 adults enrolled in the PopART study. A DSMB is an independent group composed of clinical research experts, statisticians, ethicists and community representatives that meets at regular intervals during the study to review data as it is gathered. (The study team does not have access to pivotal study data until the clinical trial ends.) The DSMB alerts the study team if anything appears to compromise the safety of study participants, if there is compelling evidence of effectiveness, or if it becomes clear that the study cannot answer a question it was designed to address.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of
infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.